Tuesday, January 31, 2017

A new study published online ahead of print in the journal Nicotine & Tobacco Research pretty much blows out of the water the hypothesis that youth e-cigarette experimentation causes kids to progress to cigarette smoking.

(See: Villanti AC, et al. Frequency of youth e-cigarette and tobacco use patterns in the U.S.: Measurement precision is critical to inform public health. Nicotine & Tobacco Research. Published online on December 24, 2016.)

The study is novel because unlike similar research reported by the Centers for Disease Control and Prevention, this one doesn't just analyze current e-cigarette use (any use in the past 30 days) but quantifies the frequency of use (number of days used in the past 30 days). In addition, he breaks down e-cigarette use at each frequency level by concomitant tobacco product usage.

The main finding of the paper is that only 0.1% of all middle- and high-school students are nonsmoking, frequent e-cigarette users (defined as those who have vaped at least 10 days of the past 30 days):

"It was rare that tobacco naive youth reported using e-cigarettes and if they did, rarer still to find them using them frequently (i.e., fewer than 0.1% used on 10 or more days per month)."

The paper criticizes all previous studies which have been cited by anti-tobacco advocates as demonstrating that e-cigarettes are a gateway to smoking for: (1) not adequately measuring the frequency of e-cigarette use and classifying youth as vapers even if they use e-cigarettes only one or twice a month; and (2) not adequately accounting for dual use of e-cigarettes and tobacco products.

The authors conclude with an admonition to tobacco control researchers: "When interpreting findings for purposes of tobacco control strategy and policymaking, care must be taken to avoid biases, confounding, over or underestimates of trajectories and interpretations of results that go beyond the limitations of the data."

The Rest of the Story

This study casts serious doubt on the claims of many anti-tobacco advocates and groups that e-cigarettes cause youth to initiate smoking. Based on the findings of this research, it is extremely rare to find nonsmoking youth who experiment with e-cigarettes and then go on to become regular vapers. It appears that most e-cigarette use among nonsmokers is infrequent and experimental, reflecting the likelihood that vaping among nonsmokers remains a purely social phenomenon without any addictive component. This makes it implausible that e-cigarettes represent a gateway to youth smoking. Further research from longitudinal studies is necessary to confirm this finding, but for now, there is no reason to believe that e-cigarette use increases the use of tobacco among adolescents.

Sunday, January 29, 2017

I have presented many examples on this blog over the past months demonstrating the fact that vaping opponents are being driven by ideology rather than science. But there is one observation I made which is dispositive. In legal terminology, dispositive means "evidencethatunqualifiedlybrings a conclusion to a legalcontroversy." This observation brings a conclusion to any controversy about whether the position and actions of vaping opponents have been science-based or ideology-based.The Rest of the StoryThe observation is actually quite simple:Not a single anti-tobacco or health group or agency which has warned the public about the risks of "popcorn lung" from vaping has warned smokers about the risks of popcorn lung.Let us assume, for a moment, that it is true that vaping puts people at risk of developing popcorn lung because it contains diacetyl, a chemical which was found to cause popcorn lung in several popcorn factory workers. Well, it turns out that cigarettes deliver hundreds of times more diacetyl to smokers than vapers get from e-cigarettes. Given the exposure difference, if diacetyl poses a risk of popcorn lung to vapers, then it certainly poses a much larger risk of popcorn lung to smokers.Yet I am unable to find a single web site of a health or anti-tobacco group that warns smokers about the risk of popcorn lung from smoking, based on the presence of high levels of diacetyl.It seems to me that if the actions of vaping opponents were science-based, then they should be plastering the headlines with warnings about the risks of popcorn lung to smokers. But they're not. They are only telling the public that e-cigarettes poses such a risk, not real cigarettes. This can only be explained by ideology: a huge bias against vaping. Without realizing it, these groups are actually defending smoking by not calling out the risks of popcorn lung.

Now the truth is that there is no evidence that vaping is associated with popcorn lung. While cigarettes deliver much higher levels of diacetyl, cigarette smoking itself has not been associated with popcorn lung. So the hysterical claims about the relationship between vaping and popcorn lung have little basis in science. But if we assume that there really is a risk of developing popcorn lung if you vape, then certainly these health groups should be warning smokers, who would face a much larger risk.

As an example, take the American Lung Association. They have a web page entitled "Popcorn Lung: A Dangerous Risk of Flavored E-Cigarettes." The first problem with this page is that it isn't true. There is no reason to believe that popcorn lung is a dangerous risk of flavored e-cigarettes. As far as I know, despite millions of e-cigarette users, there has not been a single documented case of popcorn lung caused by vaping. But the second problem is that even if we assume that the risk is real, the American Lung Association nowhere warns smokers of this risk. Shamefully, while the American Lung Association demands that "FDA act
quickly to require that diacetyl and other harmful chemicals be removed
from e-cigarettes," the Lung Association is not calling on the FDA to require that diacetyl be removed from real cigarettes.

Is this really about health, or is it just about demonizing e-cigarettes?

With that said, I
agree completely with other vaping advocates, however, that diacetyl should not
be used as a flavoring in e-cigarettes. It is not an essential ingredient, so
why use it. There is no need to even take the risk, as small as it may be.

Also, in retrospect, it may have been unreasonable to have suggested
that the ALA would ever request the FDA to have diacetyl removed from tobacco
smoke: it is a product of the combustion process in tobacco cigarettes, and it
cannot be removed.

Monday, January 23, 2017

A new study published online ahead of print in the journal Pediatrics purports to provide evidence that e-cigarettes are encouraging youth to smoke. According to the article, "youth who initiate use with e-cigarettes are more likely to start smoking conventional cigarettes." An accompanying press release concluded that "E-cigarettes are encouraging – not discouraging – youth to smoke...".

Using annual, cross-sectional data from the National Youth Tobacco Survey, the study found that the rate of decline in youth smoking from 2009-2014 was no different than the rate of decline in youth smoking from 2004 to 2009. Based on this finding, the authors conclude that experimentation with e-cigarettes did not contribute to the observed decline in smoking.

The ultimate study conclusion is that e-cigarettes have led to an increase in the "tobacco market" by attracting youth to "smoke."

The Rest of the Story

There's a major flaw in the study conclusion. And once you're aware of it, you'll realize that the study is really trying to pull the wool over the eyes of the public.

The best way I can demonstrate the trick the study is playing is through an analogy. Suppose we are interested in whether the acquisition of Al Horford led to a decline in the performance of the Boston Celtics. Controlling for a number of psychosocial variables that might affect the Celtics' performance, we find no change in the record of the Celtics from before to after Horford joined the team (this is a hypothetical example because I think they're actually playing better this year).

OK - it's time for our conclusion. And here it is:

The acquisition of Al Horford has led to an improvement in the performance of the Boston Celtics.

But wait one second. How can you conclude that the acquisition improved the Celtics' record when your analysis demonstrated that the acquisition was not associated with any change in the team's performance?

You can't. Unless you are trying to fool people.

This is exactly what is happening with this study. The researchers showed that experimentation with e-cigarettes did not lead to a decline in smoking. But that's only half the story. The rest of the story is that experimentation with e-cigarettes did not lead to an increase in smoking.

You see - it works both ways. You can't tell just the half of the story that you happen to like. If this study provides evidence that e-cigarettes didn't result in a decline in youth smoking because there was no change in the rate of decline then the study also provides evidence that e-cigarettes didn't result in an increase in youth smoking.

And that's not consistent with the authors' conclusion that e-cigarettes are encouraging youth to smoke and thereby increasing the tobacco market.

The study actually demonstrates the opposite of what the authors are telling the public. It provides evidence that e-cigarettes are not attracting kids to smoke. If that were the case, one would have expected to see lower rates of decline in youth smoking following the drastic proliferation of vaping among young people.

There is a more technical flaw with the analysis as well. The investigators choose a split point of 2009 to test the before and after trends in smoking. But there was little difference in youth smoking as measured by the NYTS between 2009 and 2011. Thus, using 2009 as the split point creates an artificially low estimate of the decline in youth smoking from 2011 to 2014. You can see from Figure 1 in the paper that there was a substantial increase in the rate of decline in youth smoking from 2011 to 2014, compared to the period from 2004 to 2011. That the model used in the paper doesn't fit the data is clear from how far off the 2011 data point is from the trend line.

The truth is that there does appear to have been an acceleration in the rate of decline in youth smoking from 2011 to 2014. This observation is consistent with results from other national surveys, including the Youth Risk Behavior Survey and the Monitoring the Future study. This doesn't mean that e-cigarettes are the reason for this accelerated decline, but it does suggest that the study has obscured the actual trend by choosing an inappropriate split point. Since e-cigarettes were not at all popular among youth in 2009 and only used by a small fraction of youth in 2011, it doesn't make sense to place the split point at 2009. Unless you're out to show that there was no change in the trend line.

The rest of the story is that by providing only half of the story, this study fools the public into believing that this research is providing evidence that e-cigarettes are encouraging kids to smoke. The truth is just the opposite. The paper also shows that e-cigarettes have not led to an increase in the youth smoking trend. There is no support for the study's conclusion that e-cigarettes are encouraging kids to smoke and thereby expanding the use of tobacco among our nation's youth.

Wednesday, January 18, 2017

Apparently, irresponsible medical advice being given to smokers about quitting is not restricted to physicians. Nurses are getting in on the act and publicly making the most reckless medical recommendations to smokers. Two egregious examples highlight the incompetent and ill-considered information being disseminated to the public in the nursing literature.

1. Smoking is No Worse than Vaping

According to an article in the current issue of the journal Nursing, two instructors at the Georgetown University School of Nursing and Health Studies claim that smoking may be no more hazardous than vaping. According to the article:

"Because e-cigarettes don't contain tobacco, they're purported to be
“less toxic” than traditional tobacco products, but the lack of
long-term research and the variability among available products makes
this claim unsubstantiated to date."

This is complete nonsense. There is abundant evidence that vaping is much safer than smoking. Even the most ardent opponents of vaping agree that although not absolutely safe, vaping is much safer than smoking. There is abundant research which
demonstrates this. But it is also common sense, as electronic cigarettes
contain no tobacco and do not involve combustion. How could they be as
dangerous as tobacco cigarettes, which we know kill more than 400,000
Americans each year? There is no legitimate scientific dispute over the
fact that vaping is much safer than smoking.

Spreading this kind of misinformation demonstrates both incompetency and a lack of responsibility. Medical practitioners should not be disseminating false health information, especially about something so important as the severe hazards of smoking. To undermine the public's appreciation of the severity of smoking's hazards by comparing real cigarettes to fake ones is doing a huge disservice to the public and to smokers in particular.

2. Smokers Who Quit Using E-Cigarettes Should Not be Commended

According to an article in the Journal of the American Association of Nurse Practitioners, nurses discourage patients who smoke from trying to quit using e-cigarettes and furthermore, they should not commend patients who have already quit smoking using e-cigarettes!

According to the article: "Currently,itisneitheradvisableforpractitionerstorecommende-cigarettesforsmokingcessation,nor isitrecommendedtocommendpatientsformakingthe switchtoe-cigaretteuseovertraditionalcigarettesmoking."

It is certainly inappropriate medical advice to discourage smokers from using e-cigarettes in a quit attempt, especially if they are highly motivated about the idea of e-cigarettes and have not had success with traditional approaches. But it is insane to recommend that nurses not commend patients who have successfully quit smoking just because they happened to achieve success using e-cigarettes. Have we completely lost our mind? I just cannot understand how a nurse could possibly be advised not to commend a patient who successfully quit smoking. It is an amazing accomplishment and the patient deserves the highest commendation for such an achievement. To withhold such a commendation simply because you don't happen to like the methods the patient used is, frankly, sick. It suggests that the health of the patient doesn't matter. What matters is that the patient quits the way this particular nurse thinks is best.It would be one thing to suggest that nurses caution smokers that e-cigarettes are not effective for everyone. But if a smoker has tried e-cigarettes and succeeded in quitting smoking, then what is there not to like? What is the problem with that? I'd call that a public health miracle. It is like a spit in the face to the estimated two million Americans who have successfully quit smoking using electronic cigarettes.

Thursday, January 12, 2017

An emergency medicine physician has warned that e-cigarettes may lead to kids breaking into homes and turning to a life of street crime in order to feed their addictions to serious drugs.

In a Huffington Postcolumn, he claims that due to e-cigarette experimentation: "teenagers — and even younger children — are getting addicted
early, which could lead to smoking, and e-cigs can easily become a
gateway to trying and developing an addiction to more serious drugs.
Addiction correlates to crime. People need to feed their habit, they
break into homes to steal things to resell, they commit robberies on the
streets, all to get money to feed their addiction."

In the column, the physician also claims that vaping causes popcorn lung: "We know that when inhaled, diacetyl causes a type of bronchitis known as
“popcorn lung” — a scarring of the tiny air sacs in the lungs resulting
in the thickening and narrowing of the airways."

To put the icing on the cake, he claims that smoking may not be any more hazardous than vaping: "The act of “vaping” is often thought of as a safer alternative to smoking, but that’s not necessarily the case."

The Rest of the Story

Not a day has passed in 2017 that an anti-tobacco group or health professional hasn't lied to the public about the health risks of e-cigarettes. The contestants for the 2017 Lie of the Year Award are already lining up in huge numbers, and it's only early January.

Just to set the records straight, there is no current evidence that e-cigarette experimentation leads to an addiction to smoking or any other drugs. There isn't even evidence that e-cigarette use causes nonsmoking youth to become addicted to vaping itself. The overwhelming majority of nonsmoking youth who have experimented with e-cigarettes have not become regular vapers. The proportion of nonsmoking youth who report having vaped in the past 30 days is substantial, but the percentage of those who vape daily - a pattern suggesting addiction - is very small. So it's a bit of a stretch perhaps to argue that a kid who tries an e-cigarette today will tomorrow be breaking into homes to feed a serious drug addiction.

There is also no evidence that vaping causes popcorn lung. Despite of the fact that there are millions of vapers in the U.S., there has not been a single reported case of popcorn lung among this population. Moreover, smoking itself has not been associated with popcorn lung, and cigarette smoking exposes users to levels of diacetyl that are hundreds of times higher than with vaping.

Finally, there is abundant evidence that smoking is far more hazardous than vaping. This is hardly surprising, since e-cigarettes do not contain tobacco and there is no combustion or smoke.

I'm sure this physician is well-intended and is just trying to protect kids from potential risks; however, I don't think we need to lie to kids or greatly exaggerate the risks. Not only is it inappropriate to lie to and mislead youth, but this strategy has been shown many times over not to work.

The rest of the story: Just remember, the kid you see blowing vape rings today in the school courtyard at recess will soon be a street criminal who is breaking into homes to feed an insatiable addiction to heroin. It's bubble gum and cotton candy vapes today, but it's smack tomorrow.

Tuesday, January 10, 2017

According to a new warning
issued by the Tennessee Department of Health (TDOH), use of electronic
cigarettes puts youth at risk of date rape. Date rape is just one of numerous
devastating consequences that the Tennessee Department of Health is linking to
electronic cigarette use, including “popcorn lung” (i.e., bronchiolitis
obliterans) and addiction to nicotine that is just as strong as heroin
addiction.

“ENDS can be
delivery systems for incapacitating agents such as gamma butyrolactone, GBL, more
commonly known as the date rape drug. According to the U.S. Drug Enforcement
Association, victims of date rape drugs are frequently not aware of ingesting
the drug, which is a central nervous system depressant and may cause
drowsiness, dizziness, nausea, loss of inhibition, memory loss and visual
disturbance. High doses will cause unconsciousness, seizures, severe
respiratory distress, coma and death. Due to induced memory loss, a victim may
not be aware of an attack until many hours after it occurred.”

The Tennessee Department of Health also warns that e-cigarette use
may cause “popcorn lung,” stating: “The
Occupational Safety and Health Administration has warned about the association
of inhaling diacetyl with a debilitating condition known as bronchiolitis
obliterans (also known as popcorn lung).”

The Department
also warns that e-cigarette use is as addictive as heroin: “People should remember that the primary ingredient of
ENDS devices is nicotine, an addictive drug that … is the most common form of
chemical dependence in the United States; research suggests it is as addictive
as heroin, cocaine or alcohol.”

The Rest of the Story

The Tennessee Department of Health would have us believe that
experimentation with electronic cigarettes is turning our kids into a generation
of nicotine-addicted junkie rapists whose lungs are rapidly obliterating and
who are facing imminent death.

Of course, the TDOH is telling a tall tale. The truth – and the
rest of the story – is that there is no evidence that e-cigarettes are
associated with any of these outcomes.

Date rape

Despite the use of e-cigarettes by millions of youth, there are no
confirmed reports of youths sneaking gamma butyrolactone into e-liquids and
then using e-cigarettes to drug peers in order to rape them. There is merely
one unconfirmed report that this may have occurred once. If the Tennessee
Department of Health were truly interested in preventing date rape, why is it
not warning that there have been many more confirmed reports of real cigarettes
being used to perpetrate date rape (although even that is not a recognized
public health problem)? Is the TDOH actually trying to prevent date rape, or is
it merely trying to demonize electronic cigarettes? I think the answer is quite
obvious.

Popcorn lung

There is no evidence that e-cigarettes cause popcorn lung. Despite
millions of e-cigarette users, there has not been a single confirmed case of
popcorn lung caused by e-cigarettes. Moreover, since the level of diacetyl in
cigarettes is 750 times higher, on average, than in e-liquids, why isn’t the
Tennessee Department of Health warning kids that smoking can cause popcorn
lung? The rest of the story is that popcorn lung has not even been associated with
smoking. There is absolutely no evidence that vaping causes popcorn lung.

Nicotine addiction

There is actually no evidence at the current time that experimentation with e-cigarettes causes nicotine addiction among youth who are not already tobacco users. We do know that despite the high percentage of youth who are trying e-cigarettes, very few are progressing to regular use and most of those who do are kids who were already smoking or using other tobacco products. The jury is still out, but there is not evidence at this time to support the contention that e-cigarettes are causing nonsmoking youth to become addicted to nicotine.In my opinion, there is no need for the Tennessee Department of Health to lie to the public. The truth should be enough. The end result of the Department's actions are to trivialize serious problems, including date rape, actual lung disease, and smoking of real cigarettes. The Department also undermines its own credibility, risking the loss of the public's trust. Finally, even if e-cigarettes were a serious public health threat, these hysterical scare tactics have been shown not to work. If anything, the Tennessee Department of Health is incredibly irresponsible because publicizing that e-cigarettes can be used to perpetrate date rape will probably lead some youth to actually try it. And that will result in more cases of e-cigarette use for date rape than have actually occurred.For this reason, I am today demanding that the Tennessee Department of Health immediately retract these claims.

Monday, January 09, 2017

Today, I am pleased to announce the winner of the 2016 Lie of the Year Award. This award is given to the health agency or organization which has
lied most egregiously to the public about smoking and/or vaping in 2016.

The nominees were: the American Thoracic Society, the University of Louisville, Johns Hopkins All Children's Hospital, the Arizona Department of Health Services, the Surgeon General of the United States, the Campaign for Tobacco-Free Kids, the Alaska Department of Health and Human Services, and the Centers for Disease Control and Prevention.

The 2016 Lie of the Year Award goes to ...

... the Centers for Disease Control and Prevention (CDC).

I have made a $100 donation to the American Vaping Association and Consumer
Advocates for Smoke-Free Alternatives Association ($50 each) in the
name of the CDC in order to help these organizations counteract the misinformation that has been provided to the public by the CDC.

Here is the award-winning entry:

Centers for Disease Control and Prevention (CDC)

Claim:There was no decline in youth tobacco use between 2011 and 2015.

The Truth: There was a substantial decline in youth tobacco use
between 2011 and 2015. Vaping is not a form of tobacco use, so it should
not be included in the figure reported by CDC.

Details: In April 2016, the CDC issued a press release stating that there was:

"No decline in overall youth tobacco use since 2011."

The Rest of the StoryThis particular false claim is actually one of a continuing series of falsehoods being disseminated by CDC to the public about electronic cigarettes. By falsely categorizing electronic cigarettes as a form of "tobacco use," the CDC has obscured from the public the fact that there have been dramatic reductions in tobacco use among youth over the past decade, with unprecedented declines in the past several years.
The only way the CDC could hide the truth from the public was to decide to classify e-cigarettes as a form of tobacco use. That allowed CDC to add the actual number of youth tobacco users and the number of e-cigarette users in 2015 and compare this sum to the number of actual youth tobacco users in 2011. Doing so turns a dramatic decline in tobacco use into a straight line and a complete lack of progress in reducing youth tobacco use. But of course, that is a lie, as youth tobacco use has dropped markedly during this time period.

The CDC's lies have continued into 2017. Today on its web site, the CDC claims that: "enhanced prevention efforts for youth are important for all forms of tobacco, including e-cigarettes." Thus, CDC is still telling the public that e-cigarettes are a form of tobacco.

But e-cigarettes are no more a form of tobacco than nicotine gum, nicotine patches, nicotine inhalers, nicotine lozenges, nicotine water, potatoes, tomatoes, eggplant, or cauliflower. All contain nicotine. And the nicotine in the first five products come from tobacco. But you don't hear the CDC going around telling smokers trying to quit using nicotine gum that they are still using a form of tobacco.

A key reason why the CDC was selected for this year's award, despite fierce competition (including the claim that smoking is no more hazardous than vaping), is that the CDC is widely listened to for health information and advice so any misinformation that it spreads is going to do a lot of harm. Moreover, it was the CDC that really initiated the backlash against e-cigarettes in the entire health and medical community, and in the media, by misleading the public in its 2009 press conference, its first major public statements about e-cigarettes.

At that press conference, the CDC tricked the public into believing that e-cigarettes were a cancer risk by reporting the finding of "tobacco-specific carcinogens" in e-cigarettes, but without also mentioning the fact that they were only found in trace amounts, that the levels were comparable to those in nicotine gum and the nicotine patch, that these trace levels were merely a result of the fact that nicotine is derived from tobacco and can't be 100% pure, and that at these low levels, there was not believed to be any significant cancer risk.

The CDC was instrumental in starting the misinformed backlash against e-cigarettes, and it has continued to lie and mislead the public to keep this campaign of demonization of e-cigarettes and vaping going. For these reasons, it is truly deserving of this award.

Friday, January 06, 2017

On Monday, the FDA will issue a new rule whose intent is to clarify the conditions under which electronic cigarettes will be regulated as drugs instead of as tobacco products. Essentially, this amounts to a rule regarding what claims electronic cigarette companies are allowed to make (since few, if any, of these companies can afford the expenses associated with preparing a new drug application).

As the FDA explains, by statute there are two claims that would make an electronic cigarette subject to regulation as a drug under the Food, Drug, and Cosmetic Act:

1) If the manufacturer makes a therapeutic claim

This means a claim that the product is intended to prevent or treat a "disease."

2) If the manufacturer makes a structure/function claim

This means a claim that the product will affect the structure or function of the body in a way different than the way cigarettes have traditionally been marketed.

So far, so good.

Under the second prong (structure/function claims), the FDA correctly points out that if an electronic cigarette were to be marketed with the intended purpose of treating nicotine dependence, preventing nicotine withdrawal, or another purpose associated with the delivery of nicotine that is not typically used with cigarettes, it would be subject to regulation as a drug.

So far, so good.

The Rest of the Story

The problem comes under the FDA's interpretation of the first prong. The FDA argues that pretty much any smoking cessation claim is inherently a therapeutic claim. While the agency does not go as far as proclaiming that there is no exception to this rule, the agency makes it clear that at first blush, any smoking cessation claim will essentially be taken to imply a therapeutic claim.

The document reviews public comments, and the response to Comment 38 is most relevant. The FDA describes the comment as follows: "FDA proposed that a product made or derived from tobacco that is intended for use in smoking cessation be subject to regulation as a medical product. Several comments objected that smoking is not a disease, but a behavior, and that a product that claims to help individuals quit smoking should not be regulated as a medical product absent any assertions that it will prevent disease or treat nicotine dependence." This appears to be my comment or at least to follow the lines of the argument that I've made several times on this blog.

In response, here is what the FDA says: "Over the past 50 years, smoking has been causally linked to diseases of nearly all organs of the body, diminished health status, and fetal harm. Most current adult smokers want to quit smoking completely for health reasons. Given these facts, we believe that statements related to quitting smoking generally create a strong suggestion that a product is intended for a therapeutic purpose. We recognize, however, that public perception can change and evidence maybe developed showing that, in some situations, “smoking cessation” is understood in context as referring to ending the use of traditional cigarettes and switching to a non-combustible product made or derived from tobacco. We have revised the codified language in §1100.5(a) in the final rule, to reflect that “smoking cessation” is one type of intended use related to “the cure or treatment of nicotine addiction."

The response is problematic because it doesn't actually address my argument. The basic argument is that smoking is not a disease, so in isolation, a claim that e-cigarettes are intended to help someone quit smoking is not necessarily a claim that the product is intended to treat a disease. The intention is to help alter a health-related behavior.

Some examples may help illustrate this concept.

Suppose I design a calendar and on each page there is an inspirational quotation intended to inspire people to engage in physical activity. Clearly, the intended use of the calendar is to help change a behavior that has substantial health implications. But it also seems clear that the FDA would not regulate my calendar as a medical device because there is no therapeutic claim. Moreover, there is a second purpose to the calendar: to keep track of appointments. The intention of the calendar is clearly not merely related to helping someone to get more exercise. The quotes could be removed and the calendar might still be useful.

If marketed carefully, e-cigarettes are similar. The primary intended use is to help change a behavior, not to treat a disease. Moreover, the intention of the product is not merely to deliver nicotine but also to serve as a recreational alternative to smoking that simulates the smoking experience. In fact, many e-cigarettes are marketed with zero nicotine e-liquids. This raises a critical point: the nicotine could be removed and e-cigarettes would still be useful to many people. There are a fair number of vapers who indeed use zero nicotine e-liquids.

If e-cigarettes are marketed in widespread fashion with no nicotine and no claims regarding the treatment of any disease, then how can they possibly be considered to be a drug or device based solely on a smoking cessation claim?

Nicotine replacement products are drugs because they are specifically intended to treat a disease: nicotine dependence. They work by delivering nicotine to prevent nicotine withdrawal. In addition, there is no nicotine replacement product that doesn't contain nicotine. The idea of a zero-nicotine patch is ridiculous. Clearly, it is not putting the patch on that is being marketed. What is being marketed is the delivery of nicotine. The patch is just the delivery mechanism.

Things are very different with e-cigarettes. While nicotine is sometimes delivered, the primary feature of the product is that it substitutes for cigarettes. It is a recreational alternative that looks and feels somewhat similar. And the delivery of nicotine is not critical to the product's purpose. Otherwise, there would be no zero-nicotine e-cigarettes on the market.

As the FDA itself points out, the approved label for nicotine replacement therapies states: "Purpose: Stop smoking aid; Use: reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking." The reduction of withdrawal symptoms is critical to the product's function. In addition, it is intended to affect the structure/function of the body because it is designed to occupy nicotine receptors in order to prevent a physiological phenomenon of nicotine withdrawal.

I am not arguing that there are never situations in which a smoking cessation claim by an e-cigarette manufacturer should be treated as a therapeutic claim. But I am arguing that making a smoking cessation claim is not dispositive of demonstrating a therapeutic intent.

The first longitudinal study that examines progression from vaping to smoking among young people has been published in the journal Addictive Behaviors. The study followed college freshmen at Virginia Commonwealth University for one year to examine whether vaping at baseline was associated with the progression from never smoking to ever and/or current smoking at follow-up.

As reported by Dr. Stan Glantz, the major finding of the study was that: "controlling for a wide range of demographic and behavioral
variables, ... e-cigarette users at baseline were about 3.4 times as
likely to be smoking cigarettes a year later as young adults who were
not using e-cigarettes."

According to Dr. Glantz, the "evidence just keeps piling up" that experimentation with e-cigarettes causes youth to become cigarette smokers.

The article itself concludes that: "Given that never-smoking participants who had tried e-cigarettes were more likely to initiate cigarette use later, limiting young adults' access to these products may be beneficial."

In other words, the paper appears to be concluding, like Dr. Glantz, that e-cigarette experimentation causes youth to become cigarette smokers.

These conclusions, if accurate, are ominous for the role of vaping as a harm reduction strategy in tobacco control because although e-cigarettes may help many smokers quit, this benefit would be largely offset if e-cigarettes also propel many youth to become smokers.

The Rest of the Story

Before you throw in the towel on the prospects for e-cigarettes as a harm reduction strategy in tobacco control, you may want to consider this:

You have only been told part of the story. There is another part to the story which is curiously omitted by Dr. Glantz and de-emphasized in the paper.

Here is the rest of the story:

The finding that "[current] e-cigarette users at baseline were about 3.4 times as
likely to be smoking cigarettes a year later as young adults who were
not using e-cigarettes" is just one finding in the paper. A second finding, which is actually more critical than the first and more relevant to the question of whether vaping leads youth to progress to regular cigarette smoking, is the following:

Current e-cigarette users at baseline were no more likely to progress to current smoking than young adults who were not using e-cigarettes.

Dr. Glantz doesn't even mention this key finding. While he reports the finding from the left column of Table 3 (the association between current vaping and ever use of cigarettes), he hides the finding from the right column of Table 3 (the association between current vaping and current use of cigarettes).

What this means is that all we know for sure about the young people who Dr. Glantz would have us believe have become smokers because of e-cigarettes is that they have at least once tried a cigarette, but that they have not smoked a cigarette in the past 30 days. So all these kids who Dr. Glantz would have us believe have been addicted to cancer sticks because of e-cigarettes are actually not current smokers. If the result of regular e-cigarette use is that while you may try a cigarette, one year later you end up not being a smoker, then vaping is doing no harm and e-cigarettes are not serving as a gateway to "a lifetime of addiction to smoking," as the CDC would like us to believe.

Why would someone who is reporting the results of this important study omit this critical finding, the key finding of the entire paper? Clearly, it's because that person is trying to hide that result from you. It's because, I think, the finding being hidden from you is damaging. It's damaging to a pre-determined conclusion that would be threatened if this finding were to be revealed.

Now the authors of the paper itself do not hide this finding completely, but they do de-emphasize it in three ways. First, they de-emphasize the finding by putting it in parentheses. In other words, while they highlight the "positive" finding (current e-cigarette use is associated with young adults trying a real cigarette), they mention the "negative" finding only parenthetically (current e-cigarette use is not associated with young adults becoming smokers).

The abstract reports the results as follows: "Ever use of e-cigarettes (but not current use) also increased participants' likelihood of being current smokers at time 2." The parentheses are not mine, but are in the original manuscript text.

Second, they omit the finding from the "highlights" to the paper, which reports that current e-cigarette use is associated with young people trying a cigarette, but hides the finding that it is not associated with young people actually becoming smokers. The authors also ignore this critical finding in the conclusion section of the abstract, where they conclude that limiting young adults' access to e-cigarettes may be beneficial even though they have not demonstrated any harms and in fact have produced evidence that there are no harms.

Third, the authors try to explain away this critical finding by pointing out that the estimate is unstable because there were so few kids who progressed from vaping to current smoking. In an apparent attempt to explain away the key finding of the paper, the authors emphasize that: "Indeed, only six initial nonsmokers transitioned from a time 1 current e-cigarette user into a current cigarette smoker at time 2."

Indeed!

And alas, that is the entire point here. Out of a sample of 3,757 college students, the investigators were only able to find six young people who transitioned from being a vaper to becoming a smoker!!!

On the other hand, there were 20 students who had used cigarettes at baseline but had ceased smoking and were using only e-cigarettes at follow-up, and there were an additional 45 students who had smoked and vaped at baseline but were only vaping at follow-up. So while e-cigarettes were associated with positive health outcomes for 65 students, they were associated with negative outcomes for just six students.

As you can see, one could easily conclude from this paper that e-cigarette use was actually beneficial to this population of college students.

I wouldn't go that far. However, I do think it is clear that the main finding of the study is that there is no evidence that vaping is causing youth to become smokers and that in fact, the paper provides strong evidence that vaping is not associated with progression to smoking. After all, only six of the 3,757 students were shown to have progressed from vaping to smoking, and those six students were no more likely to have progressed to smoking than students who were not vaping at baseline.

The rest of the story is that far from adding to the (non-existent) evidence that vaping leads youth to become smokers, this study actually provides evidence that the phenomenon of youth becoming vapers and then progressing to become smokers is actually quite rare. Thus, the study actually provides evidence that use of e-cigarettes does not lead over time to youth becoming smokers.

Thursday, January 05, 2017

In an article published on New Year's Eve in the Philadelphia Inquirer, a physician from the Philadelphia College of Osteopathic Medicine tackles what should have been a very simple question: "Are e-cigarettes any safer for my child than tobacco?"

The actual answer, based on the scientific evidence, is unequivocally "Yes." However, that's not her answer.

The Rest of the Story

Instead of simply acknowledging that e-cigarettes are indeed safer than smoking tobacco, the physician gives a five-paragraph answer in which she never actually answers the question. If anything, her dire warnings about the unknown risks of e-cigarettes seems to suggest that her answer is "No."

Certainly, a reader who is unfamiliar with the scientific literature might well come away from this article believing that vaping is just as harmful for their child than smoking.

Sadly, this is not only inaccurate, but it is a tremendous disservice to parents because if they give the same information to their children, it could have devastating public health consequences. If youth are widely led to believe that smoking is no more hazardous than vaping, then the public's appreciation of the severe hazards of smoking will be undermined. This will in turn undermine what has been a remarkably dramatic decline in youth smoking driven by the de-normalization of smoking in our society.

Equally disturbing is how ridiculous this physician's answer is. She argues that: "e-cigarettes are a potential “gateway drug” to other substances,
including traditional cigarettes, marijuana, alcohol, and crack
cocaine." I defy this physician to identify a single case in which experimentation with electronic cigarettes has led a kid to try crack cocaine. I've read the literature on this topic, and there is absolutely no evidence that vaping is a gateway to crack cocaine use.

Moreover, this claim is ridiculous on its face. Despite the skyrocketing prevalence of e-cigarette experimentation among youth in the past five years, the prevalence of all cocaine use among youth has remained extremely low, at about 0.2%. Moreover, in some sections of the country, like the Northeast, the prevalence of cocaine use among youth is virtually zero, despite extremely high levels of e-cigarette use.

It seems irresponsible of a physician to put out this blatantly false, hysterical information. She essentially blames youth use of cigarettes, marijuana, alcohol, and crack cocaine on e-cigarettes. I've boasted a good deal about the significant contributions that e-cigarettes have made, but stimulating addiction to crack cocaine is not one of them. It would be quite unfortunate if we were to look to the solution to the problem of youth smoking, marijuana, alcohol, and cocaine use by focusing on the scourge of youth blowing a few vape rings from time to time.

The article also gets its facts wrong on the basic elements of the difference between vaping and smoking. The author states that: "the current recommendation is to discourage young people from smoking anything — including e-cigarettes." But you don't smoke e-cigarettes. Vaping does not involve any combustion. In fact, that's one of the most important distinguishing characteristics between vaping and smoking (the other being that e-cigarettes do not contain tobacco).

In defense of her implication that vaping is as hazardous as smoking, the only scientific evidence that the author is able to provide is that there is: "a lack of extensive and solid research on those devices, so many questions remain about their risks."

So you mean to tell me that a product which kills more than 400,000 people each year in the U.S. is no more hazardous than one about which the worst we can say is that its long-term risks have not been quantified? The same thing could be said about many dietary supplements, whose adverse effects have not been studied in clinical trials and are therefore unknown. However, you don't hear reputable scientists going around and telling people that taking dietary supplements is as dangerous as smoking.

A physician who went around telling his patients that dietary supplements may not be any safer than smoking should probably not be treating patients.

The rest of the story is that public health advocates should not be going around telling the public that e-cigarettes may not be any safer than smoking. And they certainly shouldn't be telling parents that if their child tries a vape pen, the next thing you know they will wind up as a crack cocaine addict.

Tuesday, January 03, 2017

A new paper published online ahead of print in the journal Preventive Medicine finds that telling smokers that vaping is safer than smoking may lead them to try vaping. In the study, smokers randomized into groups that were either told that cigarettes contain many more toxic chemicals than e-cigarettes or that cigarettes and e-cigarettes contain an equal number of toxic chemicals. The smokers were then asked whether and how that might alter their interest in changing their smoking and/or vaping behavior.

The paper reports that 328 of the 1,164 smokers (28.2%) would likely be dual users of e-cigarettes and tobacco cigarettes after being told information about the relative hazards of smoking compared to vaping. Smokers who were told that e-cigarettes contain fewer harmful chemicals than vaping were much more likely to indicate an interest in dual use.

In the discussion, the paper argues that these findings have implications for the messages that the FDA delivers to the public regarding vaping products:

"FDA is required to publicly display information about the quantities of chemicals in cigarettes and cigarette smoke in a way that is not misleading. This information, if paired with information from advertising or FDA disclosures indicating that e-cigarette aerosol contains lower amounts of those same chemicals, could have the unfortunate effect of encouraging smokers to become dual users or increase their existing dual use under the mistaken impression that they are significantly reducing their health risks."

The Rest of the Story

At first glance, this study makes it appear that telling smokers that vaping is safer than smoking will have adverse public health consequences because it will lead many smokers to become or remain dual users.

But there are four major problems with this conclusion:

1. If You Only Look at the Risks, You Can't Find the Benefits

While the paper only looks at one potential consequence of telling smokers that vaping is safer (i.e., dual use), there are actually three potential outcomes, each of which was measured in this study:

the smoker might express an interest in becoming or continuing as a dual user;

the smoker might express an interest in continuing to smoke without using e-cigarettes; or

the smoker might express an interest in quitting smoking using e-cigarettes.

The first outcome, the paper argues, is a bad one for public health. The second outcome might be considered neutral, since it does not change the status quo. However, the third outcome is a profoundly positive one for public health, because these smokers, who presumably have not been able to quit (they are still current smokers) intend to quit smoking by switching completely to vaping.

Importantly, this paper only reports the proportion of smokers with the first outcome (i.e., the "bad" one). The paper does not report the proportion of smokers with the second (neutral) or third (good) outcome. Nor does the paper compare the differences in the various messages in stimulating smokers to quit using e-cigarettes (a good outcome). It only examines differences in the messages in the supposedly "bad" outcome.

For example, in the group of smokers who were told that e-cigarettes contain 100 times fewer harmful chemicals than tobacco cigarettes, the paper reports that 88 of the 276 expressed an interest in dual use. But what the paper does not examine is the outcome for the other 188 smokers. Of those 188 smokers, some expressed no interest in quitting using e-cigarettes, but presumably there were some who did. It is critical to know the number of smokers who did express an interest in quitting using e-cigarettes because that would be a very positive outcome. And without knowing the potential benefits of the various health messages, you can't possibly assess the overall public health consequences.

This is particularly problematic because the intended purpose of this research is to inform the FDA and to provide guidance to the agency in deciding what health messages to encourage, use, or allow for vaping products. By only giving the FDA one side of the story, this research hides critical information necessary to weigh potential risks and benefits.

The costs are always going to outweigh the benefits if you only quantify the risks!

Frankly, the entire research and grant portfolio of the NIH and FDA's Center for Tobacco Products is designed in exactly this way. The research is focusing on quantifying the risks associated with electronic cigarettes, but little if any work is being done to quantify the benefits.

2. Dual Use is Not Necessarily a Bad Outcome

The paper makes the assumption that dual use is a bad thing, but it might actually be a very positive development. There is solid evidence that dual use can serve as a transition on the path to eventual smoking cessation. There is also solid evidence that if a smoker is able to cut down substantially on the amount smoked, it could lessen their addiction and make it easier for them to subsequently quit smoking. Moreover, there are health benefits associated with making substantial reductions in the amount smoked, especially in terms of respiratory function and decreasing the rate of progression of lung disease.

The only way in which dual use is a bad outcome is if the smoker, in the absence of e-cigarettes, would have quit smoking. However, we know that the overwhelming majority of smokers who are attracted to e-cigarettes use these products specifically because they have been unable to quit or are not interested in quitting. It is unlikely that any significant proportion of dual users are smokers who would have quit in the absence of e-cigarettes.

3. In Public Health, We Don't Lie to the Public

Even if it is true that telling smokers that vaping is safer than smoking will encourage dual use, and even if dual use had negative public health implications, we can't lie to the public. While there might be fewer vapers if we told the public that smoking is every bit as bad as vaping, lying to the public cannot be justified because honesty and transparency are core ethical principles of the public health code of conduct. The implication of this paper is that we need to avoid telling the public the truth about the relative safety of smoking compared to vaping and that we may even need to lie about the relative risks of vaping compared to smoking.

4. The Impression that Switching from Smoking to Vaping Will Lower Health Risks is Not a "Mistaken" Impression

The paper argues that telling smokers that e-cigarettes contain fewer toxic chemicals than real cigarettes may result in "the mistaken impression that they are significantly reducing their health risks." But this is not a mistaken impression at all! It is a correct impression. Telling smokers that vaping is just about the same as smoking in terms of health risks is what is creating a mistaken impression. If there is any problem with the public's understanding of the relative risks of vaping compared to smoking, it is not the perception that vaping is safer, but instead, it is the perception that vaping is not safer than smoking.

The rest of the story is that if you only quantify the risks of a health message, you can't possibly evaluate the risk-benefit ratio because you can't find benefits if you don't look for them. In this study, only risks are quantified and although the beneficial outcome was measured, it was not analyzed or reported. To properly inform the FDA so that it can formulate rational policies, the agency needs to know about both the negative and positive consequences of a potential action. This paper is only telling part of the story.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.